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Trial registered on ANZCTR


Registration number
ACTRN12621001295831
Ethics application status
Approved
Date submitted
10/01/2021
Date registered
24/09/2021
Date last updated
24/09/2021
Date data sharing statement initially provided
24/09/2021
Date results information initially provided
24/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Managing Daily Participation via Tele-rehabilitation during the Corona Pandemic Among Breast Cancer Survivors
Scientific title
Managing Daily Participation via Tele-rehabilitation during the Corona Pandemic Among Breast Cancer Survivors
Secondary ID [1] 303129 0
Funding: Israeli Ministry of Science, Technology and Space # 3-16916
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 320235 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318171 318171 0 0
Occupational therapy
Cancer 320154 320154 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Video-conference tele-rehabilitation for women with breast cancer.
Women with breast cancer (BC) cope with decreased daily participation and quality of life (QOL)due to short and long-term physical, cognitive and emotional symptoms related to BC and medical treatments. Tele-rehabilitation offers a way to deliver rehabilitation and enhance self-management to provide strategies to reduce the impact of symptoms on daily participation and QOL. Specifically, telerehabilitation overcomes concerns regarding the vulnerable immune system, specifically in crowded places such as clinics, during pandemic.
The sessions focused on identifying occupational-focused goals, identifying barriers to participation, addressed by training and providing strategies to manage and improve women's daily participation specifically during the pandemic. Materials included women’s own daily life activities ,schedules and objects available at home to promote participation as well as cognitive and physical training.
The intervention was administered by a trained occupational therapist.
Online treatment sessions, one individual and one small group meeting were delivered using videoconferencing (ZOOM Pro) weekly for six weeks ( a total of 12 sessions for each participant). Each online treatment session lasted about 45 minutes.
Participants and the therapist were each located in their own homes, during the sessions.
The content of treatment was tailored to each participant’s needs, symptoms and occupational goals.
The first meeting was individual, focusing on understanding what changes occurred in the woman's daily activities and routines after BC and treatments, what are the symptoms that she faces and how these symptoms affect her performance and participation in daily activities. In addition, the first meeting included setting the functional meaningful goals to be achieved during the following sessions and planning a timeline. The following individual meetings included training self-management and meta-cognitive strategies needed to manage symptoms and minimize barriers to participate in the selected meaningful activities (e.g., self-knowledge, awareness and processing strategies, using cognitive strategies such as self-talk to enhance attention, reorganizing priorities, understanding activity demands, preparing weekly action plans, and utilizing potential environmental and social resources). Depending on the woman’s functional needs and motor abilities, the sessions also covered some aspects related to motor abilities (e.g., reducing range-of-motion limitations and strengthening the upper extremity). During the meetings ways to implement the weekly plan and to transfer the strategies trained during the sessions into other daily activities were discussed. During the group meetings women acquired more general self-management strategies and also shared their experiences using these strategies in their daily meaningful activities with the other women . These meetings enabled the women to discuss additional dilemmas they faced during the week in coping with other symptoms and daily activities.
To monitor adherence to the intervention, the OT set the timeline together with the woman at the first meeting. At the end of each meeting a ZOOM link for the following meeting was sent via email, and few hours before each meeting a reminder was sent to the woman via WhatsApp. In addition, the OT and the woman agreed upon assignments to be performed between the sessions. These were discussed during the following session.
Intervention code [1] 319429 0
Rehabilitation
Intervention code [2] 320961 0
Treatment: Other
Intervention code [3] 320962 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326157 0
Canadian Occupational Performance Measure
Timepoint [1] 326157 0
Pre-intervention and post- intervention (i.e. 6 weeks post intervention commencement).
Secondary outcome [1] 390269 0
Activity Card Sort:
The Activity Card Sort tool assessed level of participation in daily activities (retained activity level as compared to pre BC).
Timepoint [1] 390269 0
Pre intervention and post intervention (i.e. 6 weeks post intervention commencement).
Secondary outcome [2] 390272 0
The Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire
Timepoint [2] 390272 0
Pre-intervention and post- intervention (i.e. 6 weeks post intervention commencement).
Secondary outcome [3] 390273 0
Behavior Rating Inventory of Executive Function
Timepoint [3] 390273 0
Pre-intervention and post- intervention (i.e. 6 weeks post intervention commencement).
Secondary outcome [4] 390274 0
Functional Assessment of Cancer Therapy – Breast
Timepoint [4] 390274 0
Pre-intervention and post- intervention (i.e. 6 weeks post intervention commencement).
Secondary outcome [5] 390275 0
Self reported symptoms’ severity questionnaire was designed specifically for our previous studies and is not published as a separate questionnaire.
Timepoint [5] 390275 0
Pre-intervention and post- intervention (i.e. 6 weeks post intervention commencement).
Secondary outcome [6] 390276 0
Strategies used to manage daily participation- semi structured interview- qualitative.
Qualitative data was collected by one open-ended question: "what strategies did you use in order to retain your participation in daily activities despite the effects of BC?" We probed for elaboration on the responses, for example, regarding strategies used. This part lasted for about 15 -20 min. The woman's response was audio recorded and transcribed verbatim while assuring anonymity. The text analysis was performed inductively by two authors.
Timepoint [6] 390276 0
Pre-intervention and post- intervention (i.e. 6 weeks post intervention commencement).

Eligibility
Key inclusion criteria
Women with Invasive Carcinoma stages I–III that: a) are at least three months post-BC surgery (mastectomy or lumpectomy, unilateral or bilateral) with or without axillary dissection, b) have completed chemotherapy and radiotherapy, c) were previously healthy, and d) report difficulties or decreased participation in daily activities.
Minimum age
20 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe disability that affects daily functioning (such as severe neurological or orthopedic conditions), according to self -report.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Normal distribution was verified by Shapiro–Wilk test. Paired t-tests were used to examine differences between women's performance and performance satisfaction (Canadian Occupational Performance Measure), Quick-Disability of Arm Shoulder Hand and Behavior Rating Inventory of Executive Function-A in pre and post treatment. Wilcoxon Signed-Rank Tests were used to compare between symptoms’ severity, participation in high-demand physical activity (activity card sort) and Functional Assessment of Cancer Therapy – Breast in pre and post treatment. ANOVA repeated measures was used to compare between total Retained Activity Level (Activity Card Sort) in pre and post treatment, and MANOVA repeated measures was used to compare between its four domains in both phases. Spearman's RHO correlations were performed between symptom’s severity and participation. The qualitative data was transcribed verbatim while assuring anonymity. The text analysis was performed inductively by two authors. A thick description and validation by few participants were undertaken to ensure trustworthiness.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/05/2020
Date of last participant enrolment
Anticipated
Actual
2/07/2020
Date of last data collection
Anticipated
Actual
1/09/2020
Sample size
Target
15
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 23368 0
Israel
State/province [1] 23368 0

Funding & Sponsors
Funding source category [1] 307536 0
Government body
Name [1] 307536 0
Israeli Ministry of Science, technology and Space
Country [1] 307536 0
Israel
Primary sponsor type
University
Name
University of Haifa
Address
199 Aba Khoushy Ave.
Mount Carmel, Haifa,
Israel 3498838
Country
Israel
Secondary sponsor category [1] 308217 0
Individual
Name [1] 308217 0
Naomi Schreuer
Address [1] 308217 0
University of Haifa
199 Aba Khoushy Ave.
Mount Carmel, Haifa,
Israel 3498838
Country [1] 308217 0
Israel
Other collaborator category [1] 281584 0
Individual
Name [1] 281584 0
Khawla Loubani
Address [1] 281584 0
University of Haifa
199 Aba Khoushy Ave.
Mount Carmel, Haifa,
Israel 3498838
Country [1] 281584 0
Israel

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307602 0
Faculty of Social Welfare & Health Sciences, University of Haifa
Ethics committee address [1] 307602 0
199 Aba Khoushy Ave.
Mount Carmel
Haifa
Israel
3498838
Ethics committee country [1] 307602 0
Israel
Date submitted for ethics approval [1] 307602 0
21/04/2020
Approval date [1] 307602 0
03/05/2020
Ethics approval number [1] 307602 0
218/20

Summary
Brief summary
This pilot study aims were: (1) to investigate the impact of a short-term occupation-based tele-rehabilitation intervention on daily participation and breast cancer-related symptoms of women, and (2) to understand the women's self-perspective regarding strategies they use to maintain a satisfying daily participation and manage their symptoms during the pandemic. We hypothesized that women with BC will be able to use cognitive strategies to improve their participation in daily activities after receiving a tele-rehabilitation intervention. The intervention was delivered online twice a week for six weeks, and included one individual and one small group meeting each week, using a ZOOM Pro. The sessions focused on providing women with strategies to manage and improve their daily participation specifically during the pandemic.
Trial website
Trial related presentations / publications
Public notes
Relating to participation level before diagnosis and before COVID-19 and during COVID -19 before intervention.

Contacts
Principal investigator
Name 107822 0
Dr Rachel Kizony
Address 107822 0
University of Haifa
199 Aba Khoushy Ave.
Mount Carmel
Haifa
3498838
Country 107822 0
Israel
Phone 107822 0
+972543550898
Fax 107822 0
Email 107822 0
[email protected]
Contact person for public queries
Name 107823 0
Rachel Kizony
Address 107823 0
University of Haifa
199 Aba Khoushy Ave.
Mount Carmel
Haifa
3498838
Country 107823 0
Israel
Phone 107823 0
+972543550898
Fax 107823 0
Email 107823 0
[email protected]
Contact person for scientific queries
Name 107824 0
Rachel Kizony
Address 107824 0
University of Haifa
199 Aba Khoushy Ave.
Mount Carmel
Haifa
3498838
Country 107824 0
Israel
Phone 107824 0
+972543550898
Fax 107824 0
Email 107824 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.